Nurse Family Partnership for Women With Previous Live Births

Summary

The goal of this clinical trial is to test the Nurse Family Partnership (NFP) in mothers with previous live births (multiparous or multip individuals). The main aims are:

Specific Aim 1-Determine the effectiveness of NFP among multiparous women for reducing maternal morbidity and improving pregnancy outcomes.

Specific Aim 2-Determine the effectiveness of NFP among index children (child from pregnancy when mother was enrolled) of multiparous women for improving child outcomes.

Specific Aim 3 (Exploratory)-In preparation for a future study of the effects of preventive home-visiting programs on mother-index child-sibling triads, describe siblings (characteristics, role, influence) in the context of nurse home-visiting and evaluate the effectiveness of NFP on outcomes for prior-born siblings younger than 6 years old living in the home, including cognitive development, socioemotional development, and identification and referral to needed services.

A supplemental study to this study, led by investigators at Yale and Columbia, includes the following Aims:

Aim 1: Test whether the NFP causes variation in DNAm at Glucocorticoid-sensitive sites in infants over the first year of life.

Aim 2: Determine whether NFP causes differences in epigenetic age in infants over the first year of life.

Aim 3: Evaluate DNAm signatures as predictors of infant development at 12 months of age.

Conditions

• Pregnancy, High Risk
• Child Development
• Post Partum Depression

Interventions

BEHAVIORAL

Nurse Family Partnership

During NFP visits, the nurse: 1) engages in a therapeutic nurse-client relationship focused on promoting client abilities and behavior change to protect and promote her own health and child's health; 2) provides service coordination based on client's identified needs, referring to available community services; 3) follows NFP Visit Guidelines tailoring them to the strengths and challenges of each family; 4) works with client to support a healthy pregnancy by recognizing and reducing risk factors and promoting prenatal health care, healthy diet, exercise, and stress management; and 5) gathers data on program implementation and maternal and child health. The visits include content from six domains: personal health, environmental health, life-course, maternal role, family and friends, and health and human services. Nurses use educational materials to address the content from the six domains with their clients.

Sponsors & Collaborators

• Nationwide Children's Hospital

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Yale University

  collaborator OTHER

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Mandy A Allison, MD, MSPH · University of Colorado School of Medicine

• Deena Chisolm, PhD · Nationwide Children's Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

46 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-29

Primary Completion

2025-01-31

Completion

2025-01-31

Countries

• United States

Study Locations